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{{Short description|Finnish government agency}}
{{Infobox organization
| name = Finnish Medicines Agency
| caption = Logo of the agency
| image = Fimea_logo.png
| abbreviation = Fimea
| formation = 2009
| headquarters = Hallituskatu 12-14, [[Kuopio]], [[Finland]]
| leader_name = Eija Pelkonen
| budget = 4,8 milj. €<ref>{{Cite web |title=Talousarviotalous eli budjettitalous |url=https://www.tutkihallintoa.fi/valtio/taloustiedot/talousarviotalous-eli-budjettitalous/ |access-date=2024-02-29 |website=Tutkihallintoa.fi |language=fi}}</ref>
| budget_year = 2023
| staff = 330 (2023)
}}
The '''Finnish Medicines Agency''' ('''Fimea'''; {{Langx|sv|Säkerhets- och utvecklingscentret för läkemedelsområdet}})<ref>{{Cite web |date=2022-08-11 |title=Lyhenneluettelo: F–G |url=https://kielitoimistonohjepankki.fi/ohje/lyhenneluettelo-f-g/ |access-date=2024-02-29 |website=Kielitoimiston ohjepankki |language=fi}}</ref> is a central agency under the [[Ministry of Social Affairs and Health]] that regulates medicines, [[medical device]]s, blood and tissue products, [[biobank]]s, and develops the pharmaceutical industry.<ref name=":0">{{Cite web |title=Tietoa Fimeasta |url=https://fimea.fi/tietoa_fimeasta |access-date=2024-02-29 |website=fimea.fi}}</ref><ref>{{Cite web |title=Finnish Medicines Agency Fimea |url=https://www.suomi.fi/organization/fimea/79080517-183a-4bc1-98af-2a96e6d9c890 |access-date=2024-02-29 |website=suomi.fi}}</ref> Fimea was established in 2009, succeeding the National Agency for Medicines. Its predecessor, the National Agency for Medicines, had been operational since 1994.<ref>{{Cite web |last=Paakkanen |first=Mikko |date=2009-10-06 |title=Oikeuskansleri moittii Lääkelaitoksen pika-alueellistamista |url=http://www.hs.fi/kotimaa/artikkeli/Oikeuskansleri%2Bmoittii%2BL%C3%A4%C3%A4kelaitoksen%2Bpika-alueellistamista/1135249836832 |archive-url=https://web.archive.org/web/20091009045624/http://www.hs.fi/kotimaa/artikkeli/Oikeuskansleri+moittii+L%C3%A4%C3%A4kelaitoksen+pika-alueellistamista/1135249836832 |archive-date=2009-10-09 |access-date=2024-02-29 |website=www.hs.fi}}</ref>
== Responsibilities ==
Fimea's tasks and objectives are based on national and EU legislation, government programs, the strategy of the Ministry of Social Affairs and Health, and performance and resource management.<ref>{{Cite web |title=Sosiaali- ja terveysministeriön strategia |url=http://www.stm.fi/stm/toiminta_ja_talous/strategia/ |archive-url=https://web.archive.org/web/20110808061712/http://www.stm.fi/stm/toiminta_ja_talous/strategia/ |archive-date=2011-08-08 |access-date=2024-02-29 |website=www.stm.fi}}</ref> The agency's task areas include pharmaceutical licensing and supervision tasks, research and development, and the production and dissemination of pharmaceutical information to improve the effectiveness of pharmaceutical care and treatment.<ref name=":0" /> Fimea is part of the European medicines regulatory network and is oriented towards international cooperation.<ref name=":0" /><ref>{{Cite web |date=2024-02-23 |title=Syyhy {{!}} TS: Fimea tutkii, onko hevosten kutinavoide laiton |url=https://www.hs.fi/kotimaa/art-2000010250234.html |access-date=2024-02-29 |website=Helsingin Sanomat |language=fi}}</ref><ref>{{Cite web |title=The Finnish Medicines Agency Fimea have updated their Q&A, including questions in English |url=https://www.laakevarmennus.fi/en/news/finnish-medicines-agency-fimea-have-updated-their-qa-including-questions-english |access-date=2024-02-29 |website=Drupal |language=en}}</ref><ref>{{Cite web |last=Anttila |first=Marika |date=2024-02-23 |title=Fimea tutkii Puuilon hevosvoiteen laillisuutta ihmisten alettua käyttää sitä syyhyn hoitoon – "Tuotetta ei pidä missään nimessä sivellä ihmisen iholle" |url=https://www.ts.fi/uutiset/6252721 |access-date=2024-02-29 |website=[[Turun Sanomat]] |language=fi}}</ref>
Fimea acts as the licensing and supervisory authority for human or veterinary medicines, blood and tissue products, and pharmaceutical operators. Fimea also monitors the compliance of medical devices and pharmaceutical operators in Finland. Fimea is also responsible for coordinating national pharmaceutical development, research tasks, and evaluating pharmaceutical treatments. Fimea collects and evaluates clinical information on pharmaceutical treatments and develops treatment practices through education and information dissemination.<ref name=":0" />
Fimea's operations are funded by revenue from fee-based activities and state appropriations.
== Operations ==
Eija Pelkonen serves as Fimea's Director-General.<ref>{{Cite web |date=2023-09-13 |title=Eija Pelkonen jatkaa Fimean ylijohtajana |url=https://stm.fi/-/eija-pelkonen-jatkaa-fimean-ylijohtajana |access-date=2024-02-29 |website=Sosiaali- ja terveysministeriö |language=fi-FI}}</ref> Fimea's organizational structure was reformed in 2022 and consists of three functional areas: Marketing Authorizations, Supervision and Availability, and Safety and Effectiveness.<ref name=":1">{{Cite web |year=2023 |title=Lääkealan turvallisuus- ja kehittämiskeskus Fimean Tilinpäätös ja toimintakertomus 2022 |url=https://www.julkari.fi/handle/10024/146222 |access-date=2024-02-29 |website=www.julkari.fi}}</ref> In addition, the functional areas are supported by Shared Services, Communication Services, and Information and Development Services.<ref name=":1" />
Fimea's main office is located in [[Kuopio]]. Fimea also has offices in [[Helsinki]], [[Turku]], [[Tampere]], and [[Oulu]].<ref name=":0" />
== References ==
{{Reflist}}
{{Government agencies and public bodies of Finland}}
[[Category:Government agencies of Finland]]
[[Category:National agencies for drug regulation]]